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Clinical Trial
. 2024 May 3;14(1):10244.
doi: 10.1038/s41598-024-57013-1.

Feasibility, safety, efficacy and potential scaling-up of sofosbuvir-based HCV treatment in Central and West Africa: (TAC ANRS 12311 trial)

Karine Lacombe  1   2 , Raoul Moh  3   4 , Corine Chazallon  5 , Maud Lemoine  6 , Babacar Sylla  7 , Fatoumata Fadiga  4 , Jerôme Le Carrou  5 , Fabienne Marcellin  8 , Charles Kouanfack  9 , Laura Ciaffi  10 , Michelle Tagni Sartre  11 , Magloire Biwole Sida  12 , Alpha Diallo  13 , Joel Gozlan  14 , Moussa Seydi  15 , Viviane Cissé  16 , Christine Danel  7 , Pierre Marie Girard  17 , Thomas d'Aquin Toni  18 , Albert Minga  19 , Sylvie Boyer  9 , Patrizia Carrieri  9 , Alain Attia  20 ; TAC ANRS12311 Study Group
Collaborators, Affiliations
Clinical Trial

Feasibility, safety, efficacy and potential scaling-up of sofosbuvir-based HCV treatment in Central and West Africa: (TAC ANRS 12311 trial)

Karine Lacombe et al. Sci Rep. .

Abstract

Access to Hepatis C treatment in Sub-Saharan Africa is a clinical, public health and ethical concern. The multi-country open-label trial TAC ANRS 12311 allowed assessing the feasibility, safety, efficacy of a specific care model of HCV treatment and retreatment in patients with hepatitis C in Sub Saharan Africa. Between November 2015 and March 2017, with follow-up until mid 2019, treatment-naïve patients with HCV without decompensated cirrhosis or liver cancer were recruited to receive 12 week-treatment with either sofosbuvir + ribavirin (HCV genotype 2) or sofosbuvir + ledipasvir (genotype 1 or 4) and retreatment with sofosbuvir + velpatasvir + voxilaprevir in case of virological failure. The primary outcome was sustained virological response at 12 weeks after end of treatment (SVR12). Secondary outcomes included treatment adherence, safety and SVR12 in patients who were retreated due to non-response to first-line treatment. The model of care relied on both viral load assessment and educational sessions to increase patient awareness, adherence and health literacy. The study recruited 120 participants, 36 HIV-co-infected, and 14 cirrhotic. Only one patient discontinued treatment because of return to home country. Neither death nor severe adverse event occurred. SVR12 was reached in 107 patients (89%): (90%) in genotype 1 or 2, and 88% in GT-4. All retreated patients (n = 13) reached SVR12. HCV treatment is highly acceptable, safe and effective under this model of care. Implementation research is now needed to scale up point-of-care HCV testing and SVR assessment, along with community involvement in patient education, to achieve HCV elimination in Sub-Saharan Africa.

Keywords: Africa; Clinical trial; HIV; Hepatitis C; Sofosvubir; Viral resistance.

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Conflict of interest statement

KL received personal fees for advisory boards and conferences from MSD, Gilead, Abbvie and ViiV Healthcare, unrelated to this work. PC received research grants from MSD and Intercept, unrelated to this work. ML received research funding and consultancy fees from Gilead Sciences and ViiV Healthcare, unrelated to this work. The other authors declare no conflict of interest.

Figures

Figure 1
Figure 1
Study flow diagram.
Figure 2
Figure 2
Rates of sustained virological response at Week 24 (SVR-12) according to patients’ characteristics.
Figure 3
Figure 3
Evolution of plasma HCV-RNA level (log IU/mL).
See this image and copyright information in PMC

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